Advertisement
Review article| Volume 23, ISSUE 7, P677-682, November 2001

Download started.

Ok

Towards an international consensus on definitions and standardised outcome measures for therapeutic trials (and epidemiological studies) in West syndrome

      Abstract

      This paper argues for a standardized use of definitions and outcome measures in publications on West syndrome. Specific recommendations include the need for a validated definition of hypsarrhythmia, the use of the term non-symptomatic and abandoning the terms cryptogenic and idiopathic, talking about underlying disease association and not aetiology or cause and defining a clinical response to mean that no clinical evidence of a spasm has been seen for a specified time – 48 h was suggested. Patients should be followed up to report development – perhaps at 12–15 months and again at 2 and 5 years. Disease free survival should be reported. Side effects need to be seen as adverse events producing risk modification. Outcomes should be blind whenever possible. A consensus group will take these and other suggestions forward – please contact mailto:[email protected] if you are interested in taking part.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Brain and Development
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Hancock E.
        • Osborne J.P.
        • Milner P.
        The treatment of West Syndrome: a Cochrane review of the literature to December 2000.
        Brain Dev. 2001; 23: 624-634
        • Gibbs F.A.
        • Gibbs E.L.
        Atlas of electroencephalograpy. Epilepsy. Addison-Wesley, Cambridge, MA1952 (p. 2)
        • Friedman E.
        • Pampiglione G.
        Prognostic implications of electroencephalographic findings of hypsarrhythmia in the first year of life.
        Br Med J. 1971; 4: 323-325
        • Dulac O.
        • Plouin P.
        Cryptogenic/idiopathic West syndrome.
        in: Dulac O. Chugani H. Dalla Bernardina B. Infantile spasms and West syndrome. Saunders, London1994: 232-243
        • Appleton R.E.
        • Peters A.C.B.
        • Mumford J.P.
        • Shaw D.E.
        Randomised placebo controlled study of vigabatrin as first line treatment of infantile spasms.
        Epilepsia. 1999; 40: 1627-1633
        • de Swiet M.
        • Fayers P.
        • Shinebourne E.A.
        Blood pressure in first 10 years of life: the Brompton study.
        Br Med J. 1992; 304: 23-26
        • Lilford R.J.
        • Braunholtz D.
        The statistical basis of public policy: a paradigm shift is overdue.
        Br Med J. 1996; 313: 603-607